Informations:
Erreur:
ID
32510
Description
Study ID: 105229 Clinical Study ID: GLP105229 Study Title: A double-blinded, randomized, placebo-controlled, staggered-parallel, escalating dose study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of subcutaneous injections of GSK 716155 in healthy volunteers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: albiglutide Trade Name: Tanzeum,Eperzan Study Indication: Diabetes Mellitus, Type 2
Mots-clés
Versions (2)
- 22/10/2018 22/10/2018 -
- 06/11/2018 06/11/2018 -
Détendeur de droits
GlaxoSmithKline
Téléchargé le
6 novembre 2018
DOI
Pour une demande vous connecter.
Licence
Creative Commons BY-NC 3.0
Modèle Commentaires :
Ici, vous pouvez faire des commentaires sur le modèle. À partir des bulles de texte, vous pouvez laisser des commentaires spécifiques sur les groupes Item et les Item.
Groupe Item commentaires pour :
Item commentaires pour :
Vous devez être connecté pour pouvoir télécharger des formulaires. Veuillez vous connecter ou s’inscrire gratuitement.
Subcutaneous injections of GSK 716155 in healthy volunteers; Study ID: 105229
Similar models
Screening
- StudyEvent: ODM
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Patient date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
CL Item
Male (Male)
CL Item
Female (Female)
CL Item
Hispanic or Latino (Hispanic or Latino)
CL Item
Not Hispanic or Latino (Not Hispanic or Latino)
CL Item
African American/African Heritage (1)
CL Item
American Indian or Alaskan Native (2)
CL Item
Asian - Central/South Asian Heritage (3)
CL Item
Asian - East Asian Heritage (4)
CL Item
Asian - Japanese Heritage (5)
CL Item
Asian - South East Asian Heritage (6)
CL Item
Native Hawaiian or Other Pacific Islander (7)
CL Item
White - Arabic/North African Heritage (8)
CL Item
White - White/Caucasian/European Heritage (9)
CL Item
Post-menopausal (Post-menopausal)
CL Item
Sterile (of child-bearing age) (Sterile (of child-bearing age))
CL Item
Potentially able to bear children (Potentially able to bear children)
Physical Examination; Assessment date
Item
Date of Assessment
date
C0031809 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])
C2985720 (UMLS CUI [1,2])
Item
Hair and skin
text
C0031809 (UMLS CUI [1,1])
C0018494 (UMLS CUI [1,2])
C0558035 (UMLS CUI [1,3])
C0018494 (UMLS CUI [1,2])
C0558035 (UMLS CUI [1,3])
CL Item
Normal (Normal)
CL Item
Abnormal (Abnormal)
Item
Lymph nodes
text
C0031809 (UMLS CUI [1,1])
C0024204 (UMLS CUI [1,2])
C0024204 (UMLS CUI [1,2])
CL Item
Normal (Normal)
CL Item
Abnormal (Abnormal)
CL Item
Normal (Normal)
CL Item
Abnormal (Abnormal)
Item
Ears, Nose and Throat
text
C0031809 (UMLS CUI [1,1])
C0278350 (UMLS CUI [1,2])
C0278350 (UMLS CUI [1,2])
CL Item
Normal (Normal)
CL Item
Abnormal (Abnormal)
Item
Breasts
text
C0031809 (UMLS CUI [1,1])
C0199850 (UMLS CUI [1,2])
C0199850 (UMLS CUI [1,2])
CL Item
Normal (Normal)
CL Item
Abnormal (Abnormal)
CL Item
Not done (Not done)
Item
Respiratory
text
C0031809 (UMLS CUI [1,1])
C0035237 (UMLS CUI [1,2])
C0035237 (UMLS CUI [1,2])
CL Item
Normal (Normal)
CL Item
Abnormal (Abnormal)
Item
Cardiovascular
text
C0031809 (UMLS CUI [1,1])
C0007226 (UMLS CUI [1,2])
C0007226 (UMLS CUI [1,2])
CL Item
Normal (Normal)
CL Item
Abnormal (Abnormal)
CL Item
Normal (Normal)
CL Item
Abnormal (Abnormal)
Item
Urogenital
text
C0031809 (UMLS CUI [1,1])
C1828035 (UMLS CUI [1,2])
C1828035 (UMLS CUI [1,2])
CL Item
Normal (Normal)
CL Item
Abnormal (Abnormal)
CL Item
Not done (Not done)
CL Item
Normal (Normal)
CL Item
Abnormal (Abnormal)
CL Item
Not done (Not done)
Item
Rectal
text
C0031809 (UMLS CUI [1,1])
C0199900 (UMLS CUI [1,2])
C0199900 (UMLS CUI [1,2])
CL Item
Normal (Normal)
CL Item
Abnormal (Abnormal)
CL Item
Not done (Not done)
CL Item
Normal (Normal)
CL Item
Abnormal (Abnormal)
Item
Neurological
text
C0031809 (UMLS CUI [1,1])
C0027853 (UMLS CUI [1,2])
C0027853 (UMLS CUI [1,2])
CL Item
Normal (Normal)
CL Item
Abnormal (Abnormal)
Item
Mental Status
text
C0031809 (UMLS CUI [1,1])
C0278060 (UMLS CUI [1,2])
C0278060 (UMLS CUI [1,2])
CL Item
Normal (Normal)
CL Item
Abnormal (Abnormal)
Disease
Item
Diagnosis
text
C0012634 (UMLS CUI [1])
Disease; Current
Item
Current
boolean
C0012634 (UMLS CUI [1,1])
C0521116 (UMLS CUI [1,2])
C0521116 (UMLS CUI [1,2])
Disease; Past
Item
Past
boolean
C0012634 (UMLS CUI [1,1])
C1444637 (UMLS CUI [1,2])
C1444637 (UMLS CUI [1,2])
Vital Signs; Date in time
Item
Date
date
C0518766 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Height
Item
Height
integer
C0005823 (UMLS CUI [1])
Body Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Body Mass Index
Item
Weight
float
C1305855 (UMLS CUI [1])
Systolic Pressure
Item
Blood Pressure (sitting) - Systolic
integer
C0871470 (UMLS CUI [1])
Diastolic blood pressure
Item
Blood Pressure (sitting) - Diastolic
integer
C0428883 (UMLS CUI [1])
Heart rate
Item
Heart rate (sitting)
text
C0018810 (UMLS CUI [1])
12 lead ECG; Start Date
Item
Start Date of ECG
date
C0430456 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
12 lead ECG; Ventricular Rate
Item
Ventricular Rate
integer
C0430456 (UMLS CUI [1,1])
C2189285 (UMLS CUI [1,2])
C2189285 (UMLS CUI [1,2])
12 lead ECG; PR Interval
Item
PR Interval
integer
C0430456 (UMLS CUI [1,1])
C0429087 (UMLS CUI [1,2])
C0429087 (UMLS CUI [1,2])
12 lead ECG; QRS complex Duration
Item
QRS Duration
integer
C0430456 (UMLS CUI [1,1])
C0429025 (UMLS CUI [1,2])
C0429025 (UMLS CUI [1,2])
12 lead ECG; QT interval finding
Item
Uncorrected QT Interval
integer
C0430456 (UMLS CUI [1,1])
C1287082 (UMLS CUI [1,2])
C1287082 (UMLS CUI [1,2])
12 lead ECG; QTc Interval
Item
QTc Interval
integer
C0430456 (UMLS CUI [1,1])
C0855331 (UMLS CUI [1,2])
C0855331 (UMLS CUI [1,2])
Item
Result of the ECG
integer
C0430456 (UMLS CUI [1,1])
C0855331 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
C0855331 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
CL Item
Normal (1)
CL Item
Abnormal - Not clinically significant (2)
CL Item
Abnormal - Clinically significant (3)
Holter Electrocardiography; Start Date
Item
Start date of ECG
date
C0013801 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
Holter Electrocardiography; Start time
Item
Start time of ECG
time
C0013801 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,2])
Holter Electrocardiography; End Date
Item
End date of ECG
date
C0013801 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
Holter Electrocardiography; End time
Item
End time of ECG
time
C0013801 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,2])
Item
Result
integer
C0013801 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,2])
CL Item
Normal (1)
CL Item
Abnormal - not clinically significant (2)
CL Item
Abnormal - clinically significant (3)
CL Item
No result (not available) (4)
Item Group
Electronically transferred laboratory data - Clinical Chemistry
C0008000 (UMLS CUI-1)
Clinical Chemistry; Sampling; Date in time
Item
Date Sample Taken
date
C0008000 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Clinical Chemistry; Time
Item
Actual Time
time
C0008000 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
Item Group
Electronically transferred laboratory data - Haematology
C0474523 (UMLS CUI-1)
Hematology finding; Sampling; Date in time
Item
Date Sample Taken
date
C0474523 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Hematology finding; Time
Item
Actual Time
time
C0474523 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
Urinalysis; Sampling; Date in time
Item
Date Sample Taken
date
C0042014 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Urinalysis; Time
Item
Actual Time
time
C0042014 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
Item Group
Immunogenicity Testing; Blood
C4054739 (UMLS CUI-1)
C0005767 (UMLS CUI-2)
C0005767 (UMLS CUI-2)
Immunogenicity Study; Blood; relative time
Item
Planned Relative Time
text
C4054739 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C0439564 (UMLS CUI [1,3])
C0005767 (UMLS CUI [1,2])
C0439564 (UMLS CUI [1,3])
Immunogenicity Study; Blood; Sampling; Date in time
Item
Date Sample Taken
date
C4054739 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0005767 (UMLS CUI [1,2])
C0870078 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
Immunogenicity Study; Blood; Sampling; Time
Item
Actual Time
time
C4054739 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C0005767 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Immunogenicity Study; Blood; Sample identification number
Item
integer
C4054739 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
C1299222 (UMLS CUI [1,3])
C0005767 (UMLS CUI [1,2])
C1299222 (UMLS CUI [1,3])
Urine drug screening; Sampling; Date in Time
Item
Date sample taken
date
C0202274 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
CL Item
Positive (Positive)
CL Item
Negative (Negative)
Item
Amphetamines
text
C0202274 (UMLS CUI [1,1])
C0002667 (UMLS CUI [1,2])
C0002667 (UMLS CUI [1,2])
CL Item
Positive (Positive)
CL Item
Negative (Negative)
Item
PCP
text
C0202274 (UMLS CUI [1,1])
C0031381 (UMLS CUI [1,2])
C0031381 (UMLS CUI [1,2])
CL Item
Positive (Positive)
CL Item
Negative (Negative)
Item
Benzodiazepines
text
C0202274 (UMLS CUI [1,1])
C0005064 (UMLS CUI [1,2])
C0005064 (UMLS CUI [1,2])
CL Item
Positive (Positive)
CL Item
Negative (Negative)
Item
Cannabinoids
text
C0202274 (UMLS CUI [1,1])
C0006864 (UMLS CUI [1,2])
C0006864 (UMLS CUI [1,2])
CL Item
Positive (Positive)
CL Item
Negative (Negative)
CL Item
Positive (Positive)
CL Item
Negative (Negative)
Item
Barbiturates
text
C0202274 (UMLS CUI [1,1])
C0004745 (UMLS CUI [1,2])
C0004745 (UMLS CUI [1,2])
CL Item
Positive (Positive)
CL Item
Negative (Negative)
Item
Cotinine
text
C0202274 (UMLS CUI [1,1])
C0202363 (UMLS CUI [1,2])
C0202363 (UMLS CUI [1,2])
CL Item
Positive (Positive)
CL Item
Negative (Negative)
Item Group
Alcohol urine or breath test
C0202304 (UMLS CUI-1)
C0042036 (UMLS CUI-2)
C0202306 (UMLS CUI-3)
C0042036 (UMLS CUI-2)
C0202306 (UMLS CUI-3)
Ethanol measurement; Sampling; Date in time
Item
Date sample taken
date
C0202304 (UMLS CUI [1,1])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0870078 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
CL Item
Positive (Positive)
CL Item
Negative (Negative)
Item Group
Serology - HIV, Hepatitis B & C Screen
C0019699 (UMLS CUI-1)
C0744837 (UMLS CUI-2)
C0850489 (UMLS CUI-3)
C0744837 (UMLS CUI-2)
C0850489 (UMLS CUI-3)
HIV Seropositivity; hepatitis b serology; hepatitis C serology test; Specimen collection date
Item
Date sample taken
text
C0019699 (UMLS CUI [1,1])
C0744837 (UMLS CUI [1,2])
C0850489 (UMLS CUI [1,3])
C1302413 (UMLS CUI [1,4])
C0744837 (UMLS CUI [1,2])
C0850489 (UMLS CUI [1,3])
C1302413 (UMLS CUI [1,4])
CL Item
Positive (Positive)
CL Item
Negative (Negative)
CL Item
Positive (Positive)
CL Item
Negative (Negative)
CL Item
Positive (Positive)
CL Item
Negative (Negative)